A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01942148|
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study
Other Name: Abilify
- Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Basline and Week52 ]The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.
- Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Basline and Week52 ]The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
- Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) [ Time Frame: Baseline and Week52 ]The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942148
|Chubu Region, Japan|
|Chugoku Region, Japan|
|Hokkaido Region, Japan|
|Kansai Region, Japan|
|Kanto Region, Japan|
|Kyushu Region, Japan|
|Shikoku Region, Japan|
|Tohoku Region, Japan|
|Study Director:||Kyoji Imaoka, Mr||Otsuka Pharmaceutical Co., Ltd.|